Assessing Quality of Life of Patients With Stomach Cancer

Gastric Cancer Clinical Trial

Official title:

An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (The QLQ-STO22) In Assessing The Quality Of Life Of Patients With Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020826
• Other study ID #: EORTC-15001-40003
• Secondary ID: EORTC-15001EORTC
• Status: Completed
• Phase: N/A
• First received: July 11, 2001
• Last updated: August 24, 2012
• Start date: April 2001
• Est. completion date: January 2004

Study information

• Verified date: August 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.

Description:

OBJECTIVES:

• Determine the scale structure, reliability, and validity of the tumor-specific questionnaire, QLQ-STO22, in assessing the quality of life of patients with gastric cancer.

• Determine the questionnaire's sensitivity to change in clinical health status in these patients.

OUTLINE: Patients are stratified according to type of treatment (potentially curative vs potentially palliative), disease stage (local and locoregional vs metastatic), Karnofsky performance status (less than 80% vs more than 80%), and initial weight gain (none vs less than 10% of total body weight vs 10% or more of total body weight).

• Curatively Treated Group: Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy, 4 weeks prior to surgery, and 3 months after surgery in patients receiving neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy and/or radiotherapy following total or partial gastrectomy; and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection.

• Palliatively Treated Group: Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy.

PROJECTED ACCRUAL: Approximately 220 patients (110 per group) will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: January 2004
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed gastric adenocarcinoma

• Patients treated with curative intent according to one of the following criteria:

• Plan to undergo total or partial gastrectomy with curative intent

• Plan to receive neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent

• Prior total or partial gastrectomy with curative intent and currently receiving adjuvant chemotherapy and/or radiotherapy

• Prior endoscopic mucosal resection or laparoscopic wedge resection of early gastric cancer OR

• Patients with initial diagnosis of gastric cancer or recurrent disease with plans to receive one of the following therapies with palliative intent:

• Total or partial gastrectomy or bypass procedure

• Endoscopic procedure (e.g., stent insertion)

• Chemotherapy and/or radiotherapy

• Supportive measures only

• No concurrent enrollment on other quality of life study that would interfere with this study

• Not previously enrolled on this study

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• Any performance status

Life expectancy:

• At least 2 months for patients treated with curative intent

• At least 4 weeks for patients treated with palliative intent

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other concurrent malignancies except basal cell carcinoma of the skin

• No mental impairment that would preclude completion of questionnaire

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• quality-of-life assessment
QLQ-C30 questionnaire administered. STO22 questionnaire administered.

Locations

Country	Name	City	State
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
Germany	Universitaetsklinikum Charite	Berlin
Germany	University of Marburg	Marburg
Spain	Hospital De Navarra	Pamplona
Sweden	Sahlgrenska University Hospital	Gothenburg (Goteborg)
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Royal Infirmary	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

France,  Germany,  Spain,  Sweden,  United Kingdom, 

References & Publications (2)

Oñate-Ocaña LF, Alcántara-Pilar A, Vilar-Compte D, García-Hubard G, Rojas-Castillo E, Alvarado-Aguilar S, Carrillo JF, Blazeby JM, Aiello-Crocifoglio V. Validation of the Mexican Spanish version of the EORTC C30 and STO22 questionnaires for the evaluation — View Citation

Sadighi S, Montazeri A, Sedighi Z, Mohagheghi MA, Froutan H. Quality of life in patients with gastric cancer: translation and psychometric evaluation of the Iranian version of EORTC QLQ-STO22. BMC Cancer. 2009 Aug 28;9:305. doi: 10.1186/1471-2407-9-305. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	compliance	Proportion of completed versus expected QoL questionnaires	at the same timepoints when the QoL questionnaires are completed	No
Other	correlation between QLQ-C30 and STO22 scores	correlations between the different established scales of the QLQ-C30 and the hypothesized STO22 scales will be calculated.	before and after treatment	No
Primary	psychometric validity of the STO22 module	Quality of life scores will be evaluated for psychometric validity by: Scale structure using multi-trait scaling analysis; Reliability using tests of internal consistency; Test-retest reliability in patients recruited in the UK; Validity using inter-scale correlations and known group comparisons; Sensitivity to change using two measurements of Quality of Life and ANOVA to look for the significance of changes in quality of life scores as a function of observed changes in clinical status over time.	The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.	No
Secondary	debriefing questionnaire information	Patients will be asked to complete a short debriefing questionnaire covering questions about the time taken to complete the EORTC QLQ-C30 and QLQ-STO22; the need for help in completing the questionnaires and querying whether any of the questionnaire items were confusing; difficult to answer or upsetting.	at baseline	No